Quantcast

Industry news that matters to you.  Learn more

Exosome Diagnostics Enters Collaboration Agreement with Lilly for Exosome Blood-Based Biomarker Discovery

Exosome Diagnostics recently announced it has entered into a collaboration agreement with Eli Lilly and Company (NYSE: LLY) for biomarker discovery and validation using Exosome Diagnostics proprietary EXO50 nucleic acid extraction kit. Under the agreement, Lilly will gain early access to Exosome Diagnostics technology to help identify key gene mutations and expression levels in blood that may be correlated with drug response and disease recurrence. Financial terms were not disclosed.

“Exosome Diagnostics technology may provide a unique opportunity to gain insight into the biology of complex conditions such as cancer and immune disorders,” said Andrew Schade, senior medical director, diagnostic and experimental pathology at Lilly. “Exosome technology enables biofluid molecular sampling and the ability to monitor disease progression in real time. As Lilly explores new ways to pursue patient tailoring, we’ll continue to work with partners to expand our capabilities.”

“Accessing high quality messenger and microRNA directly from frozen patient fluid samples offers a rapid, cost-effective route to identify and validate biomarkers, which may be correlated with drug response and disease recurrence,” said James McCullough, chief executive officer of Exosome Diagnostics. “Lilly has accumulated an extensive and well annotated clinical blood sample biobank that provides a unique opportunity to track target biomarkers through the clinical trial process and help overcome the limitations of stored biopsy tissue.”

Exosomes and other microvesicles are secreted by all cells into all biofluids, and provide a natural biological packaging and distribution mechanism for RNA and DNA. Exosome Diagnostics’ rapid exosome isolation and extraction technology produces high-quality RNA and DNA, including full length mRNA and microRNA, from small volumes of patient biofluids, such as blood (serum and plasma), urine and cerebrospinal fluid, for analysis by standard PCR, array and sequencing instruments. Analysis can be performed on fresh or frozen fluid samples, allowing for broad, flexible and convenient analyses of clinical trial samples, both in real-time and retrospectively, with no special preservation methods required. Exosomes and their protected nucleic acid contents are being investigated in a broad range of diseases including cancer, CNS disorders such as Alzheimer’s and Parkinson’s disease, cardiovascular disease, maternal/fetal medicine, and chronic kidney disease, among others. In July, QIAGEN and Exosome Diagnostics signed an agreement for the creation of High-Performance Biofluid Sample Preparation Kits for Personalized Healthcare Research which covers the exclusive supply of these products upon availability in 2014.

Source: Exosome Diagnostics

MentisCura to Deploy EEG Diagnostics for Dementia at China’s Largest Geriatric Hospital in 2014

MentisCura Diagnostics (www.mentiscura.com) and WanJiaYuan International Geriatric Hospital recently announced the signing of an agreement to implement MentisCura’s proprietary diagnostic tools to improve care for patients with CNS disorders.

Mentiscura’s diagnostics will be part of a state-of-the art technology suite being deployed at the WanJiaYuan International Geriatric Hospital, expected to open in June 2014. The hospital, based in Nanyang in the Henan province, will be a 120,000 square meter, 1200 bed campus, one of the largest facilities of its kind in the world to focus solely on setting new standards of quality of managed care for the elderly, with at least 200 beds dedicated to dementia patients. WanJiaYuan International Geriatric Hospital also aims to establish a leadership position in geriatric research through the development of a center of excellence attracting over 100 international experts.

“We are honoured to be associated with a project that is of an unprecedented scale, even by international standards. The high-throughput and non-invasive nature of our electrophysiological analysis makes it uniquely useful in a real world clinical setting, where physicians need to assess patients and make care decisions before these diseases have reached a late and untreatable stage. From a five-minute standard EEG recording, our powerful analytical systems are able to provide immediate diagnostic output, offering genuine clinical benefit and scalability for even the largest facilities,” said Kristinn Gretarsson, CEO of MentisCura.

“Our hospital is committed to addressing the growing burden of care associated with diseases of ageing. We are delighted to be collaborating with MentisCura to use its innovative clinical technologies to guide earlier, lower cost diagnosis. We believe that biomarkers of disease will increasingly play an important role in our diagnostic protocol for dementia, as well as monitoring of disease progression and treatment efficacy,” commented Dr. Jin-Jing Pei, MD, Chief Physician at WanJiaYuan International Geriatric Hospital.

MentisCura offers a complete, integrated service to hospitals and general practitioners through sampling, processing and analysis of patient EEG data. The MentisCura Analysis System is a CE marked diagnostic aid, based on advanced, proprietary EEG-biomarker technology platform that accurately correlates changes in electrophysiology to specific disease pathologies, based on the company’s comprehensive proprietary EEG database for dementia and cognitive disorders. The platform supports diagnoses for most common types of dementia, including Alzheimer’s disease and Lewy body dementia.

Source: MentisCura Diagnostics

Roche and Isis Pharmaceuticals Form Alliance for Huntington’s Disease

Roche (SIX: RO, ROG; OTCQX: RHHBY) and Isis Pharmaceuticals, Inc (NASDAQ: ISIS) recently announced that they have formed an alliance to develop treatments for Huntington’s disease (HD) based on Isis’ antisense oligonucleotide (ASO) technology. This alliance combines Isis’ antisense expertise with Roche’s scientific expertise in developing neurodegenerative therapeutics. In addition, Isis and Roche will be collaborating to combine Isis’ ASOs and Roche’s proprietary “brain shuttle” program with the objective of increasing the brain penetration of ASOs with systemic administration.

Huntington’s disease is an inherited genetic brain disorder that results in the progressive loss of both mental faculties and physical control. Symptoms usually appear between the ages of 30 to 50, and worsen over a 10 to 25 year period. Ultimately, the weakened individual succumbs to pneumonia, heart failure or other complications. Presently, there is no effective treatment or cure for the disease, and current treatments focus on reducing the severity of some disease symptoms.

Initially, research will focus on Isis’ lead drug candidate that blocks production of all forms of the huntingtin (HTT) protein, the protein responsible for HD and thus has the potential to treat all HD patients. Isis is also conducting research into treatments that specifically block production of the disease-causing forms of the HTT protein which has the potential to treat subsets of HD patients. In parallel, Roche will combine its proprietary brain shuttle technology with Isis ASO technology that, if successful, will also allow systemic administration of antisense drugs to treat asymptomatic patients.

Under the terms of the agreement, Roche will make an upfront payment of $30 million to Isis, with total payments related to license fee and pre- and post-licensing milestone payments reaching potentially $362 million, including up to $80 million in potential commercial milestone payments. In addition, Isis will receive tiered royalties on sales of the drugs. Roche has the option to license the drugs from Isis through the completion of the first Phase 1 trial. Prior to option exercise, Isis is responsible for the discovery and development of an antisense drug targeting HTT protein. Roche and Isis will work collaboratively on the discovery of an antisense drug utilizing Roche’s “brain shuttle” program. If Roche exercises its option, it will be responsible for global development, regulatory and commercialization activities for all drugs arising out of the collaboration.

Commenting on the deal, Luca Santarelli, Head of Neuroscience and Small Molecules Research at Roche, said: “Huntington’s is a severely debilitating neurodegenerative disease and a large unmet medical need. Patients experience gradually worsening motor function and psychological disturbances, with a significant shortening of life expectancy after the disease is diagnosed. Treatments are urgently needed, and we believe that the Isis approach in combination with Roche’s brain shuttle represent one of the most advanced programs targeting the cause of HD with the aim of slowing down or halting the progression of this disease.”

Shafique Virani, Global Head Neuroscience, Cardiovascular & Metabolism at Roche Partnering, added: “Central to the partnership is Roche’s brain shuttle program, which we see as highly complementary to Isis’ drug development work. This dual track development program ensures whichever candidate compound proves to be most promising — Isis’ lead target or Roche’s brain shuttle version — can be taken forward to pivotal clinical trials.”

“We are pleased to be working with Roche, a global leader in drug development with significant experience in developing and commercializing drugs to treat neurological diseases. We believe that Roche’s expertise in developing CNS drugs, along with their clinical development experience, will greatly enhance our development efforts for this program and allow us to move forward more rapidly. In addition, by utilizing Roche’s brain shuttle technology with our antisense drug discovery capabilities, we have the potential to significantly improve the therapeutic potential for this program,” said B. Lynne Parshall, Chief Operating Officer of Isis. “By partnering our more complex and nuanced research and development programs earlier in development, like our Huntington’s disease CNS program, we add value and resources with partners that bring unique benefits.”

“We are excited to be working with Roche,” said Frank Bennett, Senior Vice President of Research at Isis. “We believe our mature antisense drug discovery platform is a perfect fit for Roche’s neuroscience franchise, and we anticipate a fruitful collaboration to advance our pre-clinical compounds.”

CHDI Foundation, a non-profit foundation exclusively dedicated to the development of therapies that slow the progression of HD, provided financial and scientific support to Isis’ HD drug discovery program through a development collaboration with Isis. CHDI’s support has enabled Isis to make significant progress in discovering a drug to treat HD. Together Isis and CHDI demonstrated that antisense compounds can be used to inhibit the production of HTT protein in both brain and peripheral tissues, and that the inhibition of normal HTT protein was well tolerated. Over time, CHDI will be reimbursed for its support of Isis’ program out of the milestone payments received by Isis. CHDI will receive $1.5 million associated with the signing of the Roche agreement. CHDI will continue to provide advice to Isis and Roche on the development of antisense drugs to treat patients with HD.

Isis also recognizes the tremendous benefit provided to its HD program by its academic collaborators, Drs. Don Cleveland at the Ludwig Institute, University of California San Diego and David Corey at University of Texas Southwestern. These collaborators have been instrumental in Isis’ early preclinical work demonstrating that antisense drugs can inhibit the HTT protein and produce activity in animal models of disease.

Source: Isis Pharmaceuticals

Alzheimer’s Disease and Dementia Early-Diagnostic Clinic Launched in Iceland

MentisCura Diagnostics (www.mentiscura.com) recently announced the launch of its first clinical center for the early detection of Alzheimer’s disease and other dementias. The operational launch brings sophisticated biomarkers capable of assisting early, differential diagnosis into a clinical setting and provides for the first time cutting edge electrophysiological analysis developed by MentisCura to the general public through community physicians.

Both the high prevalence and rapidly increasing incidence of CNS disorders are raising alarm on account of the growing burden of care associated with these diseases. According to data published by the Alzheimer’s Association, Alzheimer’s disease is the sixth-leading cause of death in the United States, with as many as one in eight older Americans having Alzheimer’s disease in 2012. A recent World Alzheimer’s Report estimated the 2010 worldwide cost of dementia to be more than $600bn.

“Our new service fulfills an important role addressing the key issues of earlier and more accurate diagnosis. Current diagnostic tools such as fMRI and PET are in a price range that precludes their use as screening tools for dementias. The low cost, high-throughput and non-invasive nature of our test makes it uniquely useful in a real world clinical setting, where physicians need to assess patients and make diagnostic decisions before these diseases have reached a late and untreatable stage. From a five-minute EEG recording using the international standard 10-20 testing protocol, our powerful analytical systems are able to provide same-day results back to physicians,” said Kristinn Gretarsson, CEO of MentisCura.

“MentisCura provides a welcome and reliable tool for diagnosing the causes of cognitive impairment and dementia. It plays a key role in our diagnostic protocol for dementia and is an important part of our follow up on disease progression and treatment efficacy,” commented Jon Snaedal, MD, Chief Physician of the Memory Clinic at the National Hospital of Iceland.

MentisCura’s clinic offers a complete, integrated service to hospitals and general practitioners through sampling, processing and analysis of patient EEG data. The MentisCura Analysis System is a CE marked diagnostic aid, based on advanced, proprietary EEG-biomarker technology platform that accurately maps changes in electrophysiology to specific disease pathologies, through correlation with the world´s most comprehensive proprietary EEG database for dementia and cognitive disorders. The platform supports diagnoses for most common types of dementia, including Alzheimer’s disease and Lewy Body Dementia.

Source: Business Wire

Edison Pharmaceuticals, Inc. Signs Licensing Agreement with Dainippon Sumitomo Pharma Co., Ltd. for Development & Commercialization of Orphan Mitochondrial and Adult Central Nervous System Disease Drugs

Edison Pharmaceuticals recently announced that it has entered into a research/development and commercialization agreement with Dainippon Sumitomo Pharma Co., Ltd. (DSP) for the development of EPI-743 and EPI-589 in Japan. Under the terms of the agreement, DSP will gain development and commercialization rights in Japan in exchange for Edison receiving $35 million in upfront and $15 million in R&D support. In addition, Edison will be eligible to receive $10-35 million in development milestones per indication and up to $460M in commercial milestone payments as well as royalties on commercial sales.

The initial scope of the transaction includes both pediatric orphan inherited mitochondrial and adult central nervous system diseases. Under the terms of the agreement, DSP will undertake activities required for development, approval, and commercialization of EPI-743 in Japan. The work will initially focus on orphan pediatric mitochondrial disease. Edison will retain 100% ownership and direct all research, clinical, and commercial development of EPI-743 and EPI-589 outside of Japan.

In addition, the parties will collaborate on the research and development of EPI-589 with a focus on adult central nervous system disease. This collaboration is based upon the emerging body of data implicating redox and mitochondrial dysfunction as a root cause of neurologic disorders.
Edison’s translational platform is based on redox biochemistry. It bridges key learnings derived from genetically confirmed pediatric rare mitochondrial disease to adult central nervous system disorders where redox and mitochondrial dysfunction are likely to also play a critical role.

The Edison redox platform consists of proprietary laboratory and clinical tools that enable the discovery, optimization, and clinical validation of redox-directed drugs. Specifically, through employing both laboratory and clinically derived redox signatures of disease and drug action, Edison is able to develop drugs at a fraction of the time and cost of current drug development processes, thereby reducing risk and cost and increasing the likelihood of success.

Edison will use proceeds derived from the partnership to advance the late stage development and commercialization of EPI-743 for Leigh syndrome and Friedreich’s ataxia, as well as to advance EPI-743 in other exploratory phase 2 trials for rare pediatric diseases with shared mitochondrial mechanisms.

“Our partnership with Dainippon Sumitomo Pharma will allow Edison to accelerate the development and approval of the first drug for inherited respiratory chain diseases of the mitochondria,” stated Guy Miller , MD, PhD, Chairman and CEO of Edison. “Our shared vision of the role of redox control and the mitochondria in human disease will help us extend our learnings derived from rare pediatric diseases to poorly treated acute and chronic adult CNS diseases.”

Source: PR Newswire